FDA Paves Way for Pfizer COVID Vaccines in Children

The Food and Drug Administration (FDA) on Friday paved the way for children ages 5 to 11 to receive Pfizer’s COVID-19 vaccine.

The FDA authorized the use of child-size doses – just a third of the amount given to teens and adults – for emergency use, and up to 28 million more American children could receive the vaccines starting next week.

One more regulatory hurdle remains: On Tuesday, advisers from the Centers for Disease Control and Prevention (CDC) will make more detailed recommendations on which young people should be vaccinated, and the agency director is expected to make a decision shortly after. final.

“Vaccinating younger children against COVID-19 will bring us closer to normalcy,” FDA Acting Commissioner Dr. Janet Woodcock said in a statement.

“Our thorough and rigorous evaluation of the vaccine’s safety and efficacy data should help assure parents and guardians that this vaccine meets our high standards,” the commissioner added.

A few countries have started using other COVID-19 vaccines in children under 12, including China, which has just started vaccinating 3-year-olds. But many of those using the vaccine made by Pfizer and its partner BioNTech are awaiting the US decision, and European regulators have only just begun to consider child-sized doses from companies.

With the FDA’s action, Pfizer plans to begin shipping millions of vials of the pediatric vaccine – with orange caps to avoid confusion with the purple capped doses for everyone else – to doctors’ offices, pharmacies and other vaccination sites. Once the CDC issues its ruling, eligible children will receive two vaccinations three weeks apart.

Although children are at less risk of becoming seriously ill or dying from COVID-19 than older children, children ages 5 to 11 have been severely affected, with more than 8,300 hospitalizations, a third of which required intensive care, and nearly 100 deaths since the start of the coronavirus pandemic, according to the FDA.

And with the extra-contagious delta variant circulating, the government has counted more than 2,000 coronavirus-related school closures since the beginning of the school year alone, affecting more than a million children.

“With this vaccine children can go back to something that is better than being locked up at home in distance school, not being able to see their friends,” said Dr. Kawsar Talaat of Johns Hopkins University. “The vaccine will protect them and it will also protect our communities.”

Earlier this week, the FDA’s independent scientific advisers voted that the promised benefits of the pediatric vaccine outweigh any risks. However, several members of the expert group said that it will not be necessary to vaccinate all young people, and that they preferred that vaccines be aimed at those who are at the highest risk of contracting the virus.

Nearly 70% of children ages 5 to 11 hospitalized for COVID-19 in the US have other serious medical conditions, such as asthma and obesity, according to a federal tracking. Additionally, more than two-thirds of hospitalized youth are black or Hispanic, reflecting longstanding disparities in the impact of the disease.

The question of the breadth of use of Pfizer’s vaccine will be a key consideration for the CDC and its advisers, who establish formal recommendations for pediatricians and other medical professionals.

A Pfizer study of 2,268 schoolchildren found that the vaccine was nearly 91% effective in preventing symptomatic COVID-19 infections, based on 16 cases of COVID-19 among children given the vaccine. sham vaccine, compared to the three that were vaccinated.

The children’s dose was also shown to be safe, with temporary reactions similar or minor – such as arm pain, fever or malaise – to those experienced by adolescents.

But the study was not large enough to detect extremely rare side effects, such as the inflammation of the heart that occasionally occurs after the second full dose, especially in young men and teenagers. It is not clear whether younger children who receive a smaller dose will also face that rare risk.

Some parents are expected to vaccinate their children before family gatherings around the holidays and the cold winter season.

But a recent survey from the Kaiser Family Foundation suggests that most parents will not rush to vaccinate their children. About 25% of parents surveyed earlier this month said they would vaccinate their children “immediately.” But the remaining majority of parents were roughly split between those who said they would wait to see how the vaccine worked and those who said they would “definitely” not vaccinate their children.

The similarly made Moderna vaccine is also being studied in young children, and both Pfizer and Moderna are also testing infant and preschool vaccines.

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